I. Pharmacometric modelling & simulation with Pumas.jl

Dates: November 21, 22, 23, and 24, 2021

Time: 11 AM - 3 PM (GMT+8, Taiwan time) (16 hrs in total)

Workshop faculty

Name: Dr. Vijay Ivaturi

Affiliations: University of Maryland School of Pharmacy

Workshop overview

Pharmaceutical Modelling and Simulation (Pumas) is a domain-specific extension of the Julia differential equation solver libraries for performing analyses of pharmacometric models. We will start by showing users how to implement PK/PD models with complex dosing schedules and incorporating population models. Then we will turn to the process of estimating population parameters from data. Next, the capability of Pumas to perform common pre-clinical and clinical data analytics work flows such as Non-compartmental analysis (NCA), In vitro- in vivo correlation (IVIVC), Bio-equivalence (BE) and Clinical Trial Design (CTS) will be introduced. This workshop will be a mix of demonstration and hands-on work where participants will be able to download the Pumas software and perform the analysis in real-time. At the end of the workshop, participants will have an overview of the Pumas toolkit and its utility in modern age computing.

Day 1 (Sunday, November 21)

Time

Course 1

11:00 - 11:15

Introduction and landscape overview of Pumas

11:15 - 11:45

Demo of Non-Compartmental analysis using Pumas-NCA GUI

11:45 – 12:30

Hands-on with NCA

12:30 - 12:45

Break

12:45 - 13:45

Demo Case study on Population NLME Analysis

13:45 - 15:00

Hands-on Population Pharmacokinetic Analysis

Day 2 (Monday, November 22)

Time

Course 2

11:00 - 12:00

Understanding the Pumas Model Syntax

12:00 - 12:30

Dosage Regimens, Subjects, Populations

12:30 - 12:45

Break

12:45 - 13:45

Demo Case study on simulation

13:45 - 15:00

Hands-on Simulations

Day 3 (Tuesday, November 23)

Time

Course 3

11:00 - 12:00

Understanding data requirements in Pumas

12:00 - 12:30

Fitting Workflow

12:30 - 12:45

Break

12:45 - 13:45

Demo on post-processing options

13:45 - 15:00

Hands-on post-processing

Day 4 (Wednesday, November 24)

Time

Course 4

11:00 - 12:00

Demo on Multiple response PKPD models

12:00 - 12:30

Demo on Discrete data models

12:30 - 12:45

Break

12:45 - 15:00

Hands-on case study

II. Disease Progress and Drug Action Workshop (By invitation only)

Date: November 24, 2021

Time: 9 AM - 1 PM (GMT+8, Taiwan time) (4 hrs)

Workshop faculty

Name: Professor Nick Holford

Affiliations: University of Auckland, New Zealand

Workshop overview

The objective of the workshop is to train a group of scientists experience in pharmacometrics to learn how to use disease models to understand drug treatments and to prepare them to pass on this knowledge by teaching others.

When the state of a physiological or pathophysiological process can be observed at a point in time it is called disease status. Disease progression describes the time course of the natural history of disease status. The effects of drug treatments on disease progression requires a link between drug action and disease.

The description of drug action in clinical trials may involve pharmacokinetic, pharmacodynamic, disease progress and drug action components as well as consideration of placebo or nocebo responses. A mixed effect modelling approach will be used to describe disease progress and drug action.

This workshop will review the principles of clinical pharmacology that allow disease progression and drug action to be described in terms of population pharmacometric models.